CLINUVEL announced that it has completed enrolment in its world-first study of afamelanotide as a treatment for arterial ischaemic stroke (AIS) patients. Afamelanotide treatment was well tolerated by all patients, with no adverse drug reactions reported. The Phase II afamelanotide study (CUV801) focuses on treating adult AIS patients, who are ineligible for current standard of care.

All six AIS patients treated under the CUV801 protocol are being evaluated for up to six weeks at a specialist neurological hospital in Australia, with clinical assessments made to detect changes or improvement in neurological functions and activities of daily living. Validated clinical tools are being used to evaluate the extent of patients' disability. Scientific progress has demonstrated melanocortins, including afamelanotide, provide a positive effect on the central nervous system (CNS).

Afamelanotide is known to offer neuroprotection and act as a potent anti-oxidative hormone. The drug possesses further therapeutic benefits, activating vessels, reducing fluid formation, protecting critical nerve and brain tissue, and restoring the blood brain barrier (BBB: a critical defence mechanism protecting the brain). The drug therapy is expected to improve the blood flow and increase the delivery of oxygen and nutrients to deprived brain tissue.